USPTO Patents Application 09828615

United States Patent and Trademark Office

UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office

Address: COMMISSIONER FOR PATENTS
P.O. Box 1450

Alexandria, Virginia 22313-1450
www.uspro.gov

APPLICATION NO.

FILING DATE

FIRST NAMED INVENTOR

ATTORNEY DOCKET NO.

CONFIRMATION NO. |

09/828,615

04/06/2001

William C Olson

64672/JPW/SHS/NS

5850

7590 03/02/2005

Cooper & Dunham, LLP
1 185 Avenue of the Americas
New York, NY 10036

EXAMINER

STUCKER, JEFFREY J

ART UNIT

PAPER NUMBER

1648

DATE MAILED: 03/02/2005

Please find below and/or attached an Office communication concerning this application or proceeding.

PTO-90C (Rev. 10/03)

Office Action Summary

Application No.

09/828,615

Examiner

Jeffrey Stucker

Applicants) J-

OLSON ET AL

Art Unit

1648

- The MAILING DATE of this communication appears on the cover sheet with the correspondence address -
Period for Reply

A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE 3 MONTH (S) FROM
THE MAILING DATE OF THIS COMMUNICATION.

- Extensions of time may be available under the provisions of 37 CFR 1 .136(a). In no event, however, may a reply be timely filed
after SIX (6) MONTHS from the mailing date of this communication.

• If the period for reply specified above is less than thirty (30) days, a reply within the statutory minimum of thirty (30) days will be considered timely.

- If NO period for reply is specified above, the maximum statutory period will apply and will expire SIX (6) MONTHS from the mailing date of this communication.

• Failure to reply within the set or extended period for reply will, by statute, cause the application to become ABANDONED (35 U.S.C. § 133).
Any reply received by the Office later than three months after the mailing date of this communication, even if timely filed, may reduce any
earned patent term adjustment. See 37 CFR 1 .704(b).

Status

1)^ Responsive to communication(s) filed on 16 February 2005 .
2a)D This action is FINAL. 2b)S This action is non-final.

3) D Since this application is in condition for allowance except for formal matters, prosecution as to the merits is

closed in accordance with the practice under Ex parte Quay/e, 1 935 CD. 11, 453 O.G. 21 3.

Disposition of Claims

4) ^ Claim(s) 23.25-30 and 32-49 is/are pending in the application.

4a) Of the above claim(s) is/are withdrawn from consideration.

5) Q Claim(s) is/are allowed.

6) I3 Claim(s) 23.25.26.28-30 and 32-49 is/are rejected.

7) ^ Claim(s) 27 is/are objected to.

8) D Claim(s) are subject to restriction and/or election requirement.

Application Papers

9) D The specification is objected to by the Examiner.

10) D The drawing(s) filed on is/are: a)D accepted or b)D objected to by the Examiner.

Applicant may not request that any objection to the drawing(s) be held in abeyance. See 37 CFR 1.85(a).
Replacement drawing sheet(s) including the correction is required if the drawing(s) is objected to. See 37 CFR 1.121(d).

1 1) D The oath or declaration is objected to by the Examiner. Note the attached Office Action or form PTO-152.

Priority under 35 U.S.C. § 119

12) D Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
a)D All b)D Some * c)Q None of:

1 .□ Certified copies of the priority documents have been received.

2.D Certified copies of the priority documents have been received in Application No. .

3.D Copies of the certified copies of the priority documents have been received in this National Stage
application from the International Bureau (PCT Rule 17.2(a)).
* See the attached detailed Office action for a list of the certified copies not received.

Attachment(s)

1) □ Notice of References Cited (PTO-892)

2) O Notice of Draftsperson's Patent Drawing Review (PTO-948)

3) K Information Disclosure Statement(s) (PTO-1449 or PTO/SB/08)

Paper No(s)/Mail Date 16 Feb 05 .

4) O Interview Summary (PTO-413)

Paper No(s)/Mail Date. .

5) d Notice of Informal Patent Application (PTO-152)

6) □ Other: .

U.S. Patent and Trademark Office
PTOL-326 (Rev. 1-04)

Office Action Summary

Part of Paper No./Mail Date 022805

Application/Control Number: 09/828,615 Page 2

Art Unit: 1648

This Office Action is in response to the amendment filed 16
February 2005. Claim 24 is canceled. Claims 23, 25-30, and 32-
49 are pending and rejected.

The rejection of claims 23, 24, 48, 28, 29, 30, 32, and 33
under 35 U.S.C. 102(a) as anticipated by or, in the alternative,
under 35 U.S.C. 103(a) as obvious over All away et al .
(6,107,019) is withdrawn.

The rejection of claims 23, 24, 48, 28, 29, 30, 32, and 33
under 35 U.S.C. 102(b) as anticipated by or, in the alternative,
under 35 U.S.C. 103(a) as obvious over Progenies
Pharmaceuticals, Inc. (Progenies), WO 97/47319 is withdrawn.

The rejection of claims 23-30, 32-44, 48, and 49 under 35
U.S.C. 103(a) as obvious over Allaway et al . (6,107,019) or
Progenies Pharmaceuticals, Inc. (Progenies), WO 97/47319 is
withdrawn.

The rejection of claims 23, 24, 48, and 45-47 under 35
U.S.C. 103(a) as obvious over Allaway et al . (6,107,019) or
Progenies Pharmaceuticals, Inc. (Progenies), WO 97/47319, each
in view of Cruse et al . is withdrawn.

Application/Control Number: 09/828,615
Art Unit: 164 8

Page 3

The following is a new ground of rejection.

The following is a quotation of the first paragraph of 35
U.S.C. 112:

The specification shall contain a written description of the invention,
and of the manner and process of making and using it, in such full,
clear, concise, and exact terms as to enable any person skilled in the
art to which it pertains, or with which it is most nearly connected, to
make and use the same and shall set forth the best mode contemplated by
the inventor of carrying out his invention.

Claims 23, 25, 26, 28-30, and 32-49 are rejected under 35
U.S.C. 112, first paragraph, because the specification, while
being enabling for administering antibody PA14 to reduce HIV
viral load when administered solely after viral steady state is
reached, does not reasonably provide enablement for anti-CCR5
antibodies that reduce HIV viral load when administered solely
after viral steady state is reached. The specification does not
enable any person skilled in the art to which it pertains, or
with which it is most nearly connected, to make or use the
invention commensurate in scope with these claims.

*[T]o be enabling, the specification of a patent must teach
those skilled in the art how to make and use the full scope of
the claimed invention without x undue experimentation." 7
Genentech Inc. v. Novo Nordisk 108 F.3d 1361, 1365, 42 USPQ2d
1001, 1004 (Fed. Cir. 1997); In re Wright 999 F.2d 1557, 1561,

Application/Control Number: 09/828,615
Art Unit: 1648

Page 4

27 USPQ2d 1510, 1513 (Fed. Cir. 1993); See also Amgen Inc. v.

Chugai Pharm. Co., 927 F.2d 1200, 1212, 18 USPQ2d 1016, 1026

(Fed. Cir. 1991); In re Fisher 427 F.2d 833, 839, 166 USPQ 18,

24 (CCPA 1970) . Further, in In re Wands 858 F.2d 731, 737, 8

USPQ2d 1400, 1404 (Fed. Cir. 1988) the court stated:

Factors to be considered in determining whether a
disclosure would require undue experimentation have
been summarized by the board in Ex parte Forman [230
USPQ 546, 547 (BdPatAppInt 1986)]. They include (1)
the quantity of experimentation necessary, (2) the
amount of direction or guidance presented, (3) the
presence or absence of working examples, (4) the
nature of the invention, (5) the state of the prior
art, (6) the relative skill of those in the art, (7)
the predictability or unpredictability of the art, and
(8) the breadth of the claims.

A conclusion of lack of enablement means that, based on the
evidence regarding each of the above factors, the specification,
at the time the application was filed, would not have taught one
skilled in the art how to make and/or use the full scope of the
claimed invention without undue experimentation. In re Wright,
999 F.2d 1557,1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993).

As applicant has argued in previous responses filed
8/25/03, 6/25/04, and 2/16/05, the art is uncertain as to the
predictability of using antibodies to reduce HIV viral load when
administered solely after viral steady state is reached. One
would expect that an antibody that binds to CCR5 and inhibits

Application/Control Number: 09/828,615
Art Unit: 164 8

Page 5

HIV binding to the receptor would do so at all times. However,

the review of the art suggested by applicant indicates that this

is not the case. For example, applicant directed the Examiner's

attention to two prior art references: Gauduin et al . (1997)

Nature Medicine 3: 1389-93 ( m Gauduin") and Poignard et al .

(1999) Immunity 10: 431-8 (* Poignard" ) . Gauduin and Poignard

both disclose a potently neutralizing anti-HIV-1 antibody that

potently protects against infection with HIV-1 if administered

at the time of, or up to several (6-24) hours after, viral

challenge. Poignard demonstrates, however, that the same

antibody affords little or no therapeutic benefit in subjects in

which the HIV-1 viral load had reached steady state levels prior

to administration of the antibody. In particular, Poignard

discloses the administration of, inter alia, the IgGlbl2

antibody. According to the authors of the reference:

Neutralizing antibodies can protect against challenge with
HIV-1 in vivo if present at appropriate concentrations at
the time of viral challenge, but any role in the control of
established infection is unclear (see Summary, p. 431),

The authors went on to state (at p. 434, col. 2) that:

In order to study the impact of neutralizing Abs on an
ongoing HIV-1 infection, we have administered potent
neutralizing Abs to HIV-1 infected hu-PBL-SCID mice after
the infection had been established for some days, in most
cases when the viral load had reached steady-state levels.
Our results show that passive administration of either a
single neutralizing human mAb or of a cocktail of three

Application/Control Number: 09/828,615 Page 6

Art Unit: 164 8

such Abs has minimal effect on the control of an ongoing
HIV-1 infection in the hu-PBL-SCID mouse model.

Turning to the Gauduin reference, although the IgGlbl2
antibody was found to block infection when administered after
HIV-1 challenge, this effect was obtained only when the antibody
was administered no more than several hours after viral
exposure, i.e., significantly before viral steady state reached.
In contrast, claim 23 recites that the HIV-1 viral load of the
HIV-1 infected subject is reduced when the antibody is
administered ^solely after viral steady state is reached."

The Poignard and Gauduin references thus clearly support
the contention that antibodies useful for prophylactic treatment
when administered prior infection often do not protect against
an established HIV-1 infection. Thus, based on the prior art
teachings of Poignard and Gauduin, one skilled the art the time
the invention was made could not have predicted and certainly
would not have had an expectation that treatment administered
solely after viral steady state had been reached would be
efficacious. One of ordinary skill in the art, armed with the
knowledge that an anti-HIV-1 antibody that completely protects
against acute HIV-1 infection may be completely ineffective
against chronic HIV-1 infection, could not have predicted and
would have had no reasonable expectation of success that an

Application/Control Number: 09/828,615 Page 7

Art Unit: 164 8

anti-CCR5 antibody would prove efficacious in reducing the viral
load in chronically HIV-l-inf ected subjects with steady state
HIV-I levels.

Though the antibody of Poignard and Gauduin is directed to
an epitope of HIV-1 gpl20 whereas the antibodies recited in the
instant claims are directed to an epitope of the CCR5 chemokine
receptor, the identity of the antibodies is secondary to the
general principle taught by the prior art references. Indeed,
Poignard' s results on the effect of HIV-1 neutralizing
antibodies in subjects with steady state HIV-1 levels are not
limited to a particular antibody. Instead, these results "show
that passive administration of either a single neutralizing
human mAb or of a cocktail of three such Abs has minimal effect
on the control of an ongoing HIV-1 infection in the hu-PBL-SCID
mouse model" (page 434, first paragraph of the "Discussion" in
Poignard) . Thus, the more salient principle taught by Gauduin
and Poignard is clearly that the prophylactic efficacy of an
anti-HIV-1 antibody in protecting against acute HIV-I infection
is not predictive of therapeutic efficacy against a chronic HIV-
1 infection, characterized by steady state viral levels, as
claimed in the subject invention.

The above uncertainty is not remedied by applicant's
specification which is lacking in working examples. The only

Application/Control Number: 09/828,615 Page 8

Art Unit: 164 8

working example is found on pages 96 and 97 which is directed
solely to testing the efficacy of monoclonal antibody PA14.
This example provides support for the claims limited to this
particular antibody. However, given the uncertainty of the art
in regards to treatment with antibodies after viral steady state
has been reached, this does not provide support for the full
scope of the claims.

The instant invention, based on the evidence as a whole, in
light of the factors articulated by the court in In re Wands,
lacks an enabling disclosure.

Claim 27 is objected to as being dependent upon a rejected
base claim, but would be allowable if rewritten in independent
form including all of the limitations of the base claim and any
intervening claims.

No claims are allowed.

Papers related this application may be submitted to Group
1600 by facsimile transmission. Papers should be faxed to Group
1600 via the PTO Fax Center. The faxing of such papers must
conform with the notice published in the Official Gazette, 1096
OG (November 15, 1989) .

The Group 1600 Official Fax number is: (703) 872-9306.

Information regarding the status of an application may be
obtained from the Patent Application Information Retrieval

Application/Control Number: 09/828,615
Art Unit: 1648

Page 9

(PAIR) system. Status information for published applications
may be obtained from either Private PAIR or Public PAIR. Status
information for unpublished applications is available through
Private PAIR only. For more information about the PAIR system,
see http://pair-direct.uspto.gov. Should you have questions on
access to the Private PAIR system, contact the Electronic
Business Center (EBC) at 866-217-9197 (toll-free) .

Any inquiry of a general nature or relating to the status
of this application or proceeding should be directed to the Tech
Center representative whose telephone number is (571) -272-1600 .

Any inquiry concerning this communication or earlier
communications from the examiner should be directed to Jeffrey
Stucker whose telephone number is (571) -272-0911 . The examiner
can normally be reached Monday to Thursday from 7:00am-3:30.

If attempts to reach the examiner by telephone are
unsuccessful, the examiner's supervisor, James Housel, can be
reached on (571) -272-0902 .

JEFFREY STUCKER
PRIMARY EXAMINER